The Clinical Development Physician (CDP) has primary responsibility for the planning and execution of clinical research programs involving novel therapies. Products may span all phases of clinical development (Phase 1 to Phase 3). The CDP will collaborate with key stakeholders to develop and manage the entire cycle of clinical development, including: study design, study execution, monitoring, analysis, regulatory interactions, and study reporting, and publication.
- Lead the development of clinical development plans for investigational drugs as the clinical/medical expert
- Monitor and manage the conduct of clinical trials for investigational drugs
- Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy. Be the clinical expert for study documents, clinical study reports, regulatory documents, or publications
- Participation in internal and joint internal/external project teams relevant to the development of new compounds
- Be the clinical expert and work closely with a cross-functional group of experts in operations, regulatory affairs, statistics, data management, manufacturing, medical affairs, commercial on assigned projects
- Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies
- Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of drugs
- Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility.
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
- Contribute to the assessment of business development opportunities
- Facilitate collaborations with external researchers around the world
- Travel on company business to manage future or ongoing clinical development projects
Experience & Education
- MD degree with a minimum of 5-7 years relevant clinical development experience in biotechnology/pharmaceutical industry; training in pulmonary medicine or cardiology with a background in patient care and experience in conducting human trials in pulmonary arterial hypertension required.
- Must have relevant experience in the design of clinical studies, review of data quality, safety monitoring, and the execution of trials
- Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Must have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry.
- Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
- Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred.
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills and be a strong team leader
- Title (e.g Director-Senior Director) commensurate with background and experience